1. Field of the Invention
The present invention relates to methods and systems for meeting quality standards; and more particularly, to a computer readable medium and a computer implemented system and method that enables an organization to carry on its business activities in accordance with the requirements of quality standards.
The present invention is useful for every type of business organization. However, it is particularly suited to the service aspects of a manufacturing organization or a service organization per se, and will be described in that connection.
Although the invention is important for insuring high quality process management as desired or practiced by many business organizations, or as defined by many quality control and standards organizations, it is particularly useful for complying with the applicable worldwide standards of the International Organization for Standards (ISO) and the corresponding quality standards of the American National Standards Institute, (ANSI) and being certified thereby. Thus, the present invention will be described in connection with an organizations compliance with the requirements of the applicable standards known as ISO 9000, the corresponding ASQC orf ANSI, known as Q9000, and other quality standards having similar requirements, all of which are hereafter referred to collectively as ISO 9000.
2. Description of Related Art
Customer certification of a supplier, which usually consists of an audit that insures that the supplier is complying with the terms of a contract, can become a burdensome and expensive on going task for both the supplier and the customer. Third party certification, on the other hand, may demonstrate compliance with a specifically selected quality system. In this type of certification, typically, a neutral third party examines the particular quality system of the supplier, and issues a written certification directed to that particular system. Certain companies may go through the motions of compliance with a quality standard in order to get the certificate, without actually improving quality. This, of course, can undermine the confidence of a customer not only in the publicized standard, but also in the capabilities of the supplier as well.
By complying with one or more of the applicable family of ISO standards. Suppliers are able to obtain the confidence of their customers, without the necessity of following many different quality control processes required by different customers,
The International Organization for Standardization (ISO) based in Geneva, Switzerland which has published international standards for quality management known as "ISO 9000" is the world leader for developing standards. Many companies in North America, particularly those which are interested in the global market place have adopted these standards. Additionally, the American National Standards Institute has adopted the ISO 9000 as national standard Q9000. The U.S. Department of Defense, one of the largest single consumers of goods and services developed procurement policies based on the ISO 9000. Similarly, organizations in Canada, Europe, and the Asian countries, such as Japan, China, Taiwan, Korea, and Hong Kong, for example, comply with these standards. The ISO 9004-2 standards of the ISO family of standards applies particularly to service organizations.
In order for a company to prove compliance with one or more of the ISO standards, it must be the subject of continuing audits. ISO 9000, for example, has a self auditing requirement. as well as a system for certification. Such certification is typically performed by a registered third party organization, recognized by an ISO accredited governing body. Specific requirements of the applicable ISO and ANSI standards are set forth in a publication ANSI/ASQC Q9001-1994 in an article entitled "Quality Systems-Model For Quality Assurance In Design, Development, Production, Installation And Servicing" copyrighted in 1994 by ASQC of Milwaukee, Wis., which publication is incorporated by reference.
According to ISO standards, the foundation of a quality system is its documentation, i.e., the manuals, procedures, work instructions, quality plans and quality records. The documents correspond to executive management, middle management, and work management, and the processes by which products or services are produced.
A quality manual defines the goals and objectives, the organizational structure, and the integration of the ISO 9000 and Q9001 requirements. The procedures are reference documents that explain the flow of the company's processes. The work instructions detail the elementary tasks and operations of each activity within the company. Quality plans define the quality requirements for the various products and activities. Quality records are documents that preserve pertinent information of activities carried out or results obtained.
The ISO standards require that all processes materially affecting the quality of the product or service must be documented. For example, in accordance with section 4.5 of the referenced publication, it is important to establish the company's internal guidelines detailing the rules for documentation, i.e., the drafting, management approval, verification, modification, and distribution of the documents. All documents must be numbered and presented in a preliminary version. Also, their contents must be approved before utilization and distribution. Invalid and obsolete documents must be promptly removed from all points of issue to prevent inadvertent use. There must also be a master list of documents, wherein the status and revision history must be readily available. Finally, there must be an audit trail of all documents. The appropriate personnel, of course, must then do what is written. Additionally, training must be provided each time a new document is approved. Documents must be configured with precision for the personnel that use them. Documents must be accessible to all affected personnel, at all necessary points of usage.
According to Section 4.17 a quality coordinator is required to conduct internal audits to verify and improve the implementation of the documents. According to Section 4.1.3 of the referenced publication, executive management is required to conduct regular reviews to ensure that the quality system is running smoothly. entation of the documents. Also, as required by Section 4.14, corrective or preventative action must be taken for meeting quality objectives. Once a quality system is running, the company can call a certification body for an external audit.
After the company applies for an external audit, the certification process includes a documentation review and a conformity audit. For the documentation review, the registrar verifies that the quality documentation complies with all the requirements of the standard. Following the documentation review, the company must take into account non-conformities and put in place corrective actions, so that the documentation complies with the requirements of the certification body.
From the foregoing, it is readily apparent that organizations encounter many problems in attempting to comply with the requirements of ISO 9000, the solutions to which are costly, time consuming, and requires extensive training of the personnel implementing such standards. For example, prior to the present invention, paper based electronic systems were used that not only required hard copy for performing audit trails, but also required different attestations and certifications by the personnel involved. Often additional personnel were required to administer the quqlity documentation. Also, it was difficult to make all relevant documentation available at all required work stations, as well as collecting and disposing of documentation that had become obsolete. There was also difficulty in circulating draft documents and revisions for review and approval prior to issue. It was also difficult to maintain manually a readily available up to date document master list as required by the certification body. Inordinate effort was heretofore required in quantifying the capabilities and proficiencies of sets of skills gained by employees, except through on the job training. Lastly, it is difficult to ensure timely completion, responsibility and accountabilities for action items, as well as identify the authority or the meetings which generated them.
In light of the foregoing there is a need for a method and system which permits the personnel of an organization to comply with the requirements of ISO 9000, and which overcomes one or more of the shortcomings and deficiencies of the related art.